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FDA worries about Amplichip

A long-simmering debate at FDA over the best way to regulate microarrays has come to a boil with Roche Molecular Diagnostic’s decision to market its Amplichip CYP450DNA microarray without seeking prior approval from the agency. The Amplichip thus may become a test case for the agency’s rules on microarray diagnostics.

When Roche (SWX:ROCZ,

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